Standards Documents

Technical Specification

The Technical Specification is the “master document” for ISBT 128.  It is a document that provides the specifications for coding information using ISBT 128.  It outlines how data structures should be encoded and interpreted.  Also, it provides the general requirements for labeling blood, tissue, cellular therapy, ocular, and milk products.     

*Version 4.5.0 is now available.

ST-001 Technical Specification - File Size 830 kB

 

Standard Terminology

To achieve standardization, ISBT 128 uses internationally agreed upon product definitions. All product description definitions are maintained in this document. This document is updated and given a new version number each time there is a change to the Class or Attribute tables of the ISBT 128 Product Description Code Database.  It contains the formal definitions of all classes, modifiers, and attributes used in the database. The default values for each attribute group are also specified in here.    

ST-002 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions - File Size 390 kB

Standard Terminology Version Control Sheet 2014 - File Size 22 kB

Standard Terminology Version Control Sheet 2013 - File Size 36 kB

Standard Terminology Version Control Sheet 2012 - File Size 134 kB         

Standard Terminology Version Control Sheet 2011 - File Size 40 kB

Labeling Documents

Below are the ISBT 128 Standard Labeling documents. Scroll down or click on a link to go to a particular document.

Standard Labeling - Blood

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ST-005 ISBT 128 Standard Labeling of Blood Components v1.0.0 - File Size 826 kB

This document provides a labeling guideline for ISBT 128 Blood components.  Greater detail is given for labeling than that provided in the Technical Specification.

Standard Labeling - Cellular Therapy

ST-004 ISBT 128 Standard Labeling of Cellular Therapy Products v1.1.0 - File Size 955 kB

This document provides a labeling guideline for ISBT 128 Cellular Therapy products.  Greater detail is given for labeling than that provided in the Technical Specification.

Standard Labeling - Tissues

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ST-003 ISBT 128 Standard Labeling of Human Tissue v1.0.0 - File Size 473 kB

This document provides a labeling guideline  for ISBT 128 tissues products.  Greater detail is given for labeling than that provided in the Technical Specification.

Standard Labeling - Ocular

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ST-009 ISBT 128 Standard Labeling of Ocular Tissues v1.0.0 - File Size 494 kB

This document provides a labeling guideline for ISBT 128 Ocular Tissues. Greater detail is given for labeling than that provided in the Technical Specification.

Standard Coding and Labeling - Medical Devices

ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 v1.2.0 - File Size 904 kB

The purpose of this document is to provide requirements and guidance for the labeling of medical devices containing a human tissue or cellular component using the ISBT 128 Standard.

This document is a supplement to the ISBT 128 Standard Technical Specification. It provides specific requirements and guidance for facilities labeling medical devices that contain human cells, tissues, or cellular or tissue-based products (HCT/P) that are regulated as medical devices.